Optimization of Formulation of Ambroxol Hydrochloride Orally Disintegrating Tablets by Orthogonal Test

Objective:To optimize the formulation of ambroxol hydrochloride orally disintegrating tablets.Methods:The quantity of ambroxol hydrochloride was determined with reference to the content of ambroxol hydrochloride tablets sold on market.The quantities of mannitol,microcrystalline cellulose,as well as the kinds and quantities of the taste-modifying acids were optimized by orthogonal test in which people used taste,disintegration time and dissolution as evaluation indexes.The quantity of aspartame,peppermint powder flavor and apple powder flavor were determined according to the scores for the taste from the volunteers.The quantity of magnesium stearate was determined by using powder's angle of repose as indexes,and the quantity of croscarmellose sodium was determined by adopting the conventional ratio (3%) in formulation.Results:The best formulation was as follows:ambroxol hydrochloride 30 g,mannitol 20 g,microcrystalline cellulose 40 g,citric acid 10 g,fumaric acid 10 g,aspartame 5 g,peppermint powder flavor 0.5 g,apple powder flavor 0.5 g,magnesium stearate 1 g,and croscarmellose sodium 4 g every 1 000 tablets.The taste of ambroxol hydrochloride orally disintegrating tablets prepared by using the optimized formulation were improved obviously,the disintegration time and dissolution also meet requirements,and it was biologically equivalent to ambroxol hydrochloride tablets sold on market,especially showing more rapid drug releasing.Conclusion:An optimized formulation of ambroxol hydrochloride orally disintegrating tablets which meets the requirements of the design was obtained.